BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical today announced it has submitted the final module of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Cook Zenith TX2 Thoracic Aortic Aneurysm Endovascular Graft. Cook’s PMA submission includes safety and efficacy data on approximately 230 patients who have been treated with the Cook Zenith TX2 in clinical trials at 42 sites across North America and Europe.
“Our comprehensive submission reflects the depth of the Cook Zenith TX2 clinical trial program and supports the critical safety and efficacy criteria required by the FDA approval,” said Barry Thomas, vice president of Cook Aortic Intervention. “We look forward to working with the FDA on the PMA review and bringing the Cook Zenith TX2 to physicians and patients nationwide.”